Method of surgical perforation via the delivery of energy

ABSTRACT

Apparatuses and methods for the perforation of heart tissue of a patient when an inferior approach to the heart is contraindicated are disclosed. The method includes using a superior approach to introduce the apparatus, positioning the apparatus at a tissue location and delivering a controlled amount of non-mechanical energy to the tissue to create a perforation. For example, a method of surgical perforation via the delivery of electrical, radiant or thermal energy may include: introducing an apparatus comprising an energy delivery device into a patient&#39;s heart via the patient&#39;s superior vena cava; positioning the energy delivery device at a first location adjacent material to be perforated; and perforating the material by delivering energy via the energy delivery device; wherein the energy is selected from the group consisting of electrical energy, radiant energy and thermal energy.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.11/265,304, filed Nov. 3, 2005, now issued as U.S. Pat. No. 7,947,940.U.S. application Ser. No. 11/265,304 is a continuation-in-part of U.S.application Ser. No. 10/666,301, filed Sep. 19, 2003, now issued as U.S.Pat. No. 7,048,733 and a continuation-in-part of U.S. application Ser.No. 10/760,479, filed Jan. 21, 2004, now issued as U.S. Pat. No.7,270,662 and a continuation-in-part of U.S. application Ser. No.10/666,288, now abandoned, filed Sep. 19, 2003, which is acontinuation-in-part of U.S. application Ser. No. 10/347,366, filed Jan.21, 2003, now issued as U.S. Pat. No. 7,112,197. Co-pending U.S.application Ser. No. 11/265,304 claims priority from U.S. provisionalapplication Ser. No. 60/522,753, filed Nov. 3, 2004.

TECHNICAL FIELD

This disclosure relates to a method, and device therefore, for creatinga surgical perforation via energy delivery.

BACKGROUND OF THE ART

Trans-septal catherization procedures typically involve insertion of aneedle, such as the trans-septal needle of Cook Incorporated(Bloomington, Ind., USA) into a patient's heart. The needle comprises astiff metal cannula with a sharpened distal tip. The needle is generallyintroduced through a dilator and guiding sheath set in the femoral veinand advanced through the vasculature into the right atrium. From therethe needle tip is positioned at the fossa ovalis, the preferred locationon the septum for creating a puncture.

A trans-jugular approach, using a needle to gain trans-septal access, isdescribed by Joseph et. al. (1997). Joseph states that trans-jugularseptal puncture may find application in cardiac electrophysiologybecause it offers a more direct approach to the mitral annulus, leftventricle, and inferior aspect of the left atrium. In anotherpublication by Joseph et. al. (2000), the author states that intransvenous mitral valvuloplasty, the jugular approach simplifies septalpuncture and mitral valve crossing in patients with a huge left atriumand distorted anatomy, besides making the procedure feasible in thepresence of obstruction of the inferior vena cava. However, needletrans-septal punctures from the jugular approach are more difficult toperform and require significant practice. Cheng (2003), commenting onthe aforementioned articles, states that the transjugular approach fortrans-septal needle puncture is more difficult to perform than thetransfemoral approach and that only with larger studies and moreexperience will we be able to tell whether the innovative tranjugularapproach is as versatile, efficacious, and safe as the conventionaltransfemoral approach.

The SafeSheath® CSG Worley, described in the publication entitled “Usingthe Pressure Products SafeSheath CSG Worley with Radio OpaqueSoft-Tipped Braided Core” is a surgical sheath designed to be introducedinto a patient's heart through the Superior Vena Cava (SVC) and onthrough the coronary sinus. The SafeSheath® device is not intended orstructured to allow for perforation of patient material nor is itstructured to allow for positioning within a patient's heart forperforation and/or dilation.

U.S. Pat. No. 7,056,294 to Khairkhahan et al discloses a method thatuses mechanical force to gain transseptal access. The method includespositioning a needle against material and mechanically advancing theneedle to gain transseptal access. In one particular embodiment, the tipof a sheath-dilator-transseptal needle combination is placed in thedesired location against the fossa ovalis and the transseptal needle isabruptly advanced to accomplish a quick puncture. The needle preferablycomprises a tubular structure such as a stainless steel hypotube havinga sharpened distal end. Some embodiments include additional mechanicaladvancement means such as cutting edges or a corkscrew thread. Thedisclosed method does not include using RF energy to perforate theseptum and gain transseptal access.

U.S. Pat. No. 6,814,733 to Schwartz et al includes a method of ablationto create circumferential lesions in the myocardial sleeve of thepulmonary vein to block electrical propagation between the pulmonaryvein and the left atrium. Schwartz teaches conventional mechanicalneedle perforation of the interatrial septum. The method includes aneedle and guide-wire crossing the septum before an energy deliverycoil. Optionally, as a substitute for using a dilator, the coil can beenergized for ablation of septal tissue to ease the passage of acatheter through the septum. This method can include using energy toenlarge an already existing perforation in a septum, but it does notinclude using energy to perforate a septum. The method's preferredapproach to the heart is from an inferior direction.

SUMMARY OF THE INVENTION

The safe perforation of heart tissue of a patient when an inferiorapproach to the heart is contraindicated can be accomplished byintroducing an apparatus using a superior approach, positioning theapparatus at the correct tissue location and delivering a controlledamount of non-mechanical energy to the tissue.

In a first broad aspect, embodiments of the present invention include amethod of surgical perforation via the delivery of electrical, radiantor thermal energy comprising the steps of: (i) introducing an apparatuscomprising an energy delivery device into a patient's heart via thepatient's superior vena cava; (ii) positioning the energy deliverydevice at a first location adjacent material to be perforated; and (iii)perforating the material by delivering energy via the energy deliverydevice. The energy is selected from the group consisting of electricalenergy, radiant energy and thermal energy.

In some embodiments of the first broad aspect, step (ii) comprisespositioning the energy delivery device at an angle of about 80 degreesto about 100 degrees relative to the material to be perforated, whereinsome embodiments comprise positioning the energy delivery devicesubstantially perpendicularly relative to the material to be perforated.

Some embodiments of the first broad aspect further comprise a step of:(iv) advancing the energy delivery device to a second location throughthe perforation. Some such embodiments yet further comprise theapparatus including a distal region capable of adopting a curved shapeand wherein step (iv) further comprises directing a distal tip of theapparatus in a desired direction. Step (iv) can include the distal tipbeing directed away from cardiac structures in order to decrease risk ofunwanted injury.

Some embodiments that comprise the step (iv) of advancing the energydelivery device to the second location through the perforation furtherinclude that the second location is a left atrium of the patient'sheart. The apparatus of some such embodiments further comprises at leastone pressure sensing mechanism selected from the group consisting of apressure-transmitting lumen and a pressure transducer and theseembodiments may further comprise a step of measuring pressure.

Methods of the first aspect can include that the apparatus furthercomprises an orientation indicator for determining a direction of thedistal tip and that the method comprises monitoring the orientationindicator. Methods may additionally comprise staining at least a portionof the first location with a radiopaque dye.

Some embodiments of the first broad aspect include that the step ofintroducing an apparatus comprises the steps of: (a) introducing theapparatus into the patient's vasculature; and (b) advancing theapparatus through the patient's vasculature into the patient's heart.Such methods may include that step (a) comprises inserting the apparatusinto a vein selected from the group consisting of a jugular vein, asubclavian vein, a brachial vein and an axillary vein.

In some embodiments, the step (i) of introducing an apparatus comprisingan energy delivery device into a patient's heart via the patient'ssuperior vena cava further comprises inserting a dilator and a sheathinto the patient's heart, and can additionally comprise advancing theenergy delivery device, the dilator and the sheath to a second locationthrough the perforation, and can further comprise that the dilator isshaped such that a distal end of the dilator will be advanced throughthe perforation upon an application of a longitudinal force onto aproximal end of the dilator.

Some methods of the first broad aspect, wherein step (i) comprisesinserting a dilator and a sheath into the patient's heart, furthercomprise the dilator being articulating and/or the sheath beingarticulating. Some examples include that the apparatus further comprisesan elongated support and that the method further comprises inserting theelongated support into a lumen defined by the dilator prior to step (i)and that, additionally, the method may further comprise removing theelongated support after perforating the material.

In some embodiments, the step (ii) of positioning the energy deliverydevice at a first location further comprises positioning the dilatorsuch that a distal end of the dilator is oriented at an angle of about80 degrees to about 100 degrees relative to the material to beperforated and can additionally comprise positioning the dilator suchthat the distal end of the dilator is oriented substantiallyperpendicularly relative to the material to be perforated.

In some embodiments of the first broad aspect, the material to beperforated is tissue of an atrial septum of the patient's heart and cancomprise a fossa ovalis of the patient's heart.

In some embodiments, the method further comprises a step of deliveringone or more of a treatment device, a diagnostic device and a treatmentcomposition through the perforation.

In some embodiments of the first broad aspect, the energy comprisesnon-continuous radio frequency energy i.e. pulsed radio frequencyenergy. Some embodiments for pulsed radio frequency energy compriseradio frequency energy of not more than 60 watts, a voltage from about200 Vrms to about 400 Vrms and a duty cycle of about 5% to about 50% atabout 0 Hz to about 10 Hz. Some embodiments comprise radio frequencyenergy of not more than 60 watts, a voltage from about 240 Vrms to about300 Vrms and a duty cycle of 5% to 40% at 1 Hz, with possibly, thepulsed radio frequency energy being delivered for a maximum of 10seconds. In some examples, the pulsed radio frequency energy comprisesradio frequency energy of not more than 50 watts, a voltage of about 270Vrms, and a duty cycle of about 10% at 1 Hz. In other examples, thepulsed radio frequency energy comprises radio frequency energy of notmore than 50 watts, a voltage of about 270 Vrms, and a duty cycle ofabout 30% at 1 Hz.

Some embodiments of the first broad aspect comprise a method wherein alength of the energy delivery device is about 0.10 cm to about 0.20 cmand an outer diameter of the energy delivery device is about 0.02 cm toabout 0.06 cm. In some examples, the length of the energy deliverydevice is about 0.14 cm and the outer diameter of the energy deliverydevice is about 0.04 cm (0.016″). In some such embodiments the energy isdelivered as a continuous wave at a frequency between about 400 kHz andabout 550 kHz and a voltage of between about 100 to about 200 V RMS.

In a second broad aspect, embodiments of the present invention include amethod of surgical perforation via the delivery of electrical, radiantor thermal energy comprising the steps of: (i) introducing an apparatuscomprising an energy delivery device into a patient's heart via thepatient's superior vena cava; and (ii) delivering energy via the energydelivery device to perforate a septum of the heart. The energy isselected from the group consisting of electrical energy, radiant energyand thermal energy.

In a third broad aspect, embodiments include a method of surgicalperforation via the delivery of electrical, radiant or thermal energycomprising the steps of: (i) introducing an apparatus comprising anenergy delivery device into a patient's heart via the patient's superiorvena cava; and (ii) perforating material at a first location bydelivering energy via the energy delivery device. The energy is selectedfrom the group consisting of electrical energy, radiant energy andthermal energy.

In a fourth broad aspect of the present invention, embodiments include amethod of surgical perforation comprising the steps of: (i) introducingan apparatus comprising an energy delivery device into a patient's heartvia the patient's superior vena cava; and (ii) perforating material ofthe heart by delivering energy via the energy delivery device whereinthe energy is not mechanical energy.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the invention may be readily understood, embodiments ofthe invention are illustrated by way of examples in the accompanyingdrawings, in which:

FIG. 1 illustrates a schematic view of an electrosurgical systemincluding an electrosurgical device in accordance with an embodiment ofthe invention;

FIG. 2 illustrates a side cross-sectional view of the device of FIG. 1;

FIG. 3 illustrates a cross-sectional view of an alternate embodiment ofthe device;

FIG. 4 illustrates an active electrode of the device of FIG. 1;

FIG. 5 illustrates the distal region of a device in accordance with analternate embodiment of the invention;

FIG. 6 illustrates a side cross-sectional view of an alternateembodiment of the device;

FIG. 7 illustrates a side cross-sectional view of an alternateembodiment of the device;

FIGS. 8A and 8B illustrate two possible embodiments of a guiding sheath;

FIG. 9 illustrates one embodiment of a dilator;

FIGS. 10A, 10B and 10C illustrate alternate embodiments of a dilator;

FIG. 11 illustrates a first position of one embodiment of the presentinvention within a patient's heart;

FIG. 12 illustrates a second position of one embodiment of the presentinvention within a patient's heart;

FIGS. 13A and 13B illustrate first positions of alternate embodiments ofthe present invention within a patient's heart;

FIGS. 14A and 14B illustrate second positions of alternate embodimentsof the present invention within a patient's heart;

FIG. 15 illustrates a position of one embodiment of a guiding sheath ofthe present invention within a patient's heart; and

FIGS. 16A and 16B illustrate a flow chart of a trans-septal perforationmethod in accordance with an embodiment of this invention.

It will be noted that throughout the appended drawings, like featuresare identified by like reference numerals.

DETAILED DESCRIPTION OF THE INVENTION

The perforation or puncture of a patient's heart tissue when an inferiorapproach to the heart is contraindicated can be accomplished byintroducing an electrosurgical apparatus using a superior approach, thatis, an approach from above a patient's heart. The apparatus can then bepositioned and a controlled amount of non-mechanical energy can then bedelivered to tissue to create the perforation or puncture.

Definitions

Mechanical Energy

A relevant definition of mechanical energy is “a combination of kineticand potential energy resulting from the movement or release of a machinecomponent, such as a wheel or spring”. The definition is not intended toinclude thermal or electrical energy.

RF Ablation vs. RF Perforation

Benson et. al. (2002) discusses the fundamental differences between RFablation and RF perforation. In an RF perforation procedure, energy isapplied to rapidly increase tissue temperature to the extent that theintracellular fluid becomes converted to steam, inducing cell lysis as aresult of elevated pressure within the cell. Upon the occurrence of celllysis and rupture, a void is created, allowing the tip of the catheterto penetrate the tissue. In order to achieve this effect, RF perforationdevices must apply a high voltage to the tissue region over a shortperiod of time. Also, the tip of the device being used should berelatively small, in order to increase the impedance of the device. Thisis in contrast to RF ablation, whereby a larger-tipped device isutilized to deliver a low impedance and high power signal to the regioninvolved. Furthermore, as opposed to RF perforation, which creates avoid in the tissue through which the device may be advanced, theobjective of RF ablation is to create a large, non-penetrating lesion inthe tissue, in order to disrupt electrical conduction. Thus, for thepurposes of the present invention, perforation is defined as thecreation of a void within a material.

With specific reference now to the drawings in detail, it is stressedthat the particulars shown are by way of example and for purposes ofillustrative discussion of embodiments of the present invention only,and are presented in the cause of providing what is believed to be themost useful and readily understood description of the principles andconceptual aspects of the invention. In this regard, no attempt is madeto show structural details of the invention in more detail than isnecessary for a fundamental understanding of the invention, thedescription taken with the drawings making apparent to those skilled inthe art how the several forms of the invention may be embodied inpractice.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not limited in its applicationto the details of construction and the arrangement of the components setforth in the following description or illustrated in the drawings. Theinvention is capable of other embodiments or of being practiced orcarried out in various ways. Also, it is to be understood that thephraseology and terminology employed herein is for the purpose ofdescription and should not be regarded as limiting.

In this description, the term “about” refers to possible smallmodifications in numerical values that would be known to the readerskilled in the art to not change clinically the outcome of theprocedure.

Electrosurgical Device

FIG. 1 illustrates an embodiment of an apparatus 102 in a system 100.Apparatus 102 comprises an elongate member 104 having a distal region106, and a proximal region 108. Distal region 106 is adapted to beinserted within and along a lumen of a body of a patient, such as apatient's vasculature, and maneuverable therethrough to a desiredlocation proximate material, such as tissue, to be perforated.

In some embodiments, the elongate member 104 may be tubular inconfiguration, having at least one lumen extending from proximal region108 to distal region 106 such as lumen 200 shown in FIG. 2. Elongatemember 104 may be constructed of a biocompatible polymer material thatprovides column strength to apparatus 102. The elongate member 104 issufficiently stiff to permit a dilator 910 and a guiding sheath 800 (SeeFIG. 8) to be easily advanced over apparatus 102 and through aperforation. Examples of suitable materials for the tubular portion ofelongate member 104 are polyetheretherketone (PEEK), and polyimide. Inthe illustrated embodiment, the outer diameter along the tubular portionof elongate member 104 tapers down to distal region 106. In alternateembodiments, the outer diameter along elongate member 104 remainssubstantially constant from proximal region 108 to distal region 106.

Distal region 106 is constructed of a softer polymer material so that itis pliable and atraumatic when advanced through vasculature. In someembodiments, the material is also formable, so that its shape can bechanged during manufacturing, typically by exposing it to heat while itis fixed in a desired shape. In an alternate embodiment, the shape ofdistal region is modifiable by the operator during use. An example of asuitable plastic is Pebax (a registered trademark of Atofina Chemicals,Inc.). In the present embodiment, the distal region 106 comprises acurve portion 115. Referring to FIG. 12, as the distal region 106 isadvanced out of a guiding sheath, it curls away from the general axis ofthe sheath which helps ensure that energy delivery device 112 is not ina position to inadvertently injure unwanted areas within a patient'sheart after trans-septal perforation. Curve length may be about 4 cm(about 1.57″) to about 6 cm (about 2.36″) and the curve may traverseabout 225 to about 315 degrees of the circumference of a circle. Forexample, the curve may be about 5 cm in length and may traverse about270 degrees of the circumference of a circle. Such an embodiment may beuseful to avoid unwanted damage to cardiac structures.

In some embodiments, curve portion 115 begins about 0.5 cm to about 1.5cm proximal to energy delivery device 112, leaving an approximately 1 cm(about 0.39″) straight portion in the distal region 106 of apparatus102. This ensures that this initial portion of apparatus 102 will exitdilator 910 (see FIG. 9 below) without curving, enabling the operator toeasily position the apparatus 102, for example, against a septum asdescribed further below. This feature further ensures that the distalregion 106 of apparatus 102 will not begin curving within the atrialseptum.

Distal region 106 may have a smaller outer diameter compared to theremainder of elongate member 104 so that dilation of a perforation islimited while the distal region 106 is advanced through the perforation.Limiting dilation ensures that the perforation will not causehemodynamic instability once apparatus 102 is removed. In someembodiments, the outer diameter of distal region 106 may be no largerthan about 0.8 mm to about 1.0 mm. For example, the outer diameter ofdistal region 106 may be about 0.9 mm (about 0.035″). This is comparableto the distal outer diameter of the trans-septal needle that istraditionally used for creating a perforation in the atrial septum.Similarly, in some embodiments, the outer diameter of elongate member104 may be no larger than about 0.040″ to about 0.060″. For example, theouter diameter of elongate member 104 may be about 0.050″ (1.282 mm),which is also comparable to the trans-septal needle dimensions.

Distal region 106 terminates at functional tip region 110, whichcomprises a device that functions as an energy delivery device as wellas an ECG measuring device. Functional tip region 110 comprises at leastone energy delivery device 112 made of a conductive and radiopaquematerial, such as stainless steel, tungsten, platinum, or another metal.One or more radiopaque markings (not shown) may be affixed to elongatemember 104 to highlight the location of the transition from distalregion 106 to the remainder of elongate member 104, or other importantlandmarks on apparatus 102. Alternately, the entire distal region 106 ofapparatus 102 may be radiopaque. This can be achieved by filling thepolymer material, for example Pebax, used to construct distal region 106with radiopaque filler. An example of suitable radiopaque filler isBismuth. Distal region 106 may contain at least one opening 109 which isin fluid communication with main lumen 200 (FIG. 2) as described furtherbelow.

In the illustrated embodiment, proximal region 108 comprises a hub 114,to which are attached a catheter connector cable 116, and connector 118.Tubing 117 and adapter 119 are attached to hub 114 as well. Proximalregion 108 may also have one or more depth markings 113 to indicatedistances from functional tip region 110, or other important landmarkson apparatus 102. Hub 114 comprises a curve direction or orientationindicator 111 that is located on the same side of apparatus 102 as thecurve 115 in order to indicate the direction of curve 115. Orientationindicator 111 may comprise inks, etching, or other materials thatenhance visualization or tactile sensation. One or more curve directionindicators may be used and they may be of any suitable shape and sizeand a location thereof may be varied about the proximal region 108.

In the illustrated embodiment, adapter 119 is configured to releaseablycouple apparatus 102 to an external pressure transducer 121 via externaltubing 123. External pressure transducer 121 is coupled to a monitoringsystem 125 that converts a pressure signal from external pressuretransducer 121 and displays pressure as a function of time. Catheterconnector cable 116 connects to Electro-cardiogram (ECG) interface unit120 via connector 118. ECG connector cable 122 connects ECG interfaceunit 120 to ECG recorder 126, which displays and captures ECG signals asa function of time. Generator connector cable 124 connects ECG interfaceunit 120 to an energy source such as generator 128. In this embodiment,ECG interface unit 120 functions as a splitter, permitting connection ofelectrosurgical apparatus 102 to both ECG recorder 126 and generator 128simultaneously. ECG signals can be continuously monitored and recordedand the filtering circuit within ECG interface unit 120 may permitenergy, for example RF energy, to be delivered from generator 128through electrosurgical apparatus 102 without compromising ECG recorder126.

In another embodiment (not shown) of apparatus 102, there may be acontrol mechanism associated with the distal region 106 of apparatus 102and an operating mechanism to operate said control mechanism associatedwith the proximal region 108 of apparatus 102. The control mechanism maybe used to steer or otherwise actuate at least a portion of distalregion 106.

Generator 128 may be a radiofrequency (RF) electrical generator that isdesigned to work in a high impedance range. Because of the small size ofenergy delivery device 112 the impedance encountered during RF energyapplication is very high. General electrosurgical generators aretypically not designed to deliver energy in these impedance ranges, soonly certain RF generators can be used with this device. In oneembodiment, the energy is delivered as a continuous wave at a frequencybetween about 400 kHz and about 550 kHz, a voltage of between 100 to 200V RMS and a duration of up to 99 seconds. An appropriate generator forthis application is the BMC RF Perforation Generator (model numberRFP-100, Baylis Medical Company, Montreal, Canada). This generatordelivers continuous RF energy at about 460 kHz. A grounding pad 130 iscoupled to generator 128 for attaching to a patient to provide a returnpath for the RF energy when generator 128 is operated in a monopolarmode.

Other embodiments could use pulsed or non-continuous RF energy. Someembodiments for pulsed radio frequency energy have radio frequencyenergy of not more than about 60 watts, a voltage from about 200 Vrms toabout 400 Vrms and a duty cycle of about 5% to about 50% at about fromslightly more than 0 Hz to about 10 Hz. More specific embodimentsinclude radio frequency energy of not more than about 60 watts, avoltage from about 240 Vrms to about 300 Vrms and a duty cycle of 5% to40% at 1 Hz, with possibly, the pulsed radio frequency energy beingdelivered for a maximum of 10 seconds. An appropriate generator for thisapplication is the BMC RF Perforation Generator model number RFP-200(Baylis Medical Company, Montreal, Canada). This generator can be set toprovide pulsed radio frequency energy of not more than about 50 watts, avoltage of about 270 Vrms, and a duty cycle of about 10% at 1 Hz.Alternatively, the pulsed radio frequency energy could comprise radiofrequency energy of not more than about 50 watts, a voltage of about 270Vrms, and a duty cycle of about 30% at 1 Hz.

In still other embodiments of apparatus 102, different energy sourcesmay be used, such as radiant (e.g. laser), ultrasound, thermal or otherfrequencies of electrical energy (e.g. microwave), with appropriateenergy sources, coupling devices and delivery devices.

Referring to FIG. 2 a cross-section of apparatus 102 is illustrated inaccordance with the embodiment of FIG. 1. Functional tip region 110comprises an energy delivery device 112 that is coupled to an insulatedconducting wire 202. Conducting wire 202 may be attached to distalregion 106 using an adhesive. Alternately, distal region 106 may bemelted onto insulation 204 on conducting wire 202 to form a bond.

Conducting wire 202 carries electrical energy from generator 128 to theenergy delivery device 112. Conducting wire 202 also carries actionpotentials or voltage measured by energy delivery device 112 to ECGrecorder 126. Action potentials or voltage measured by energy deliverydevice 112 is with reference to a zero potential or ground electrode(not shown) within ECG recorder 126 or with reference to a groundelectrode (not shown) attached to the patient (not shown). Conductingwire 202 is covered with electrical insulation 204 made of abiocompatible material that is able to withstand high temperatures suchas polytetrafluoroethylene (PTFE), or other insulating material.Conducting wire 202 may extend through a main lumen 200 of apparatus102, which lumen may extend from proximal region 108 to distal region106.

In an alternate embodiment shown in cross section view in FIG. 3, anelongate member 300 comprises main lumen 302 and a separate lumen 304.The separate lumen 304 contains a conducting wire 306 covered withelectrical insulation 308 and main lumen 302 can be used for aspirationof blood and injection of contrast (e.g. for staining) and other media.This embodiment of elongate member 300 allows a dedicated lumen for eachfunction of apparatus 102. In yet further embodiments, apparatus 102 maynot comprise a lumen and the present invention is not limited in thisregard.

In the embodiment of FIG. 2, main lumen 200 extends from proximal region108 along elongate member 104 and through distal region 106 of apparatus102. At least one opening 109 at the distal region 106 provides apathway between main lumen 200 and the environment surrounding distalregion 106, such as a desired location within a patient's body. Openings109 may be sufficiently dimensioned to easily aspirate blood to andthrough main lumen 200 and to inject radiopaque contrast; however,openings 109 may be limited in number and dimension so that they do notcompromise the structural integrity of distal region 106. In order tofacilitate even distribution of contrast agent and to prevent pooling inmain lumen 200 at distal region 106, openings 109 may be dimensionedsuch that distally located openings are larger than proximally locatedopenings. The location of openings 109 is as close to energy deliverydevice 112 as possible so that only a small portion of apparatus 102 isrequired to extend from dilator 910 and sheath 800 in order to measurepressure. In this embodiment, adapter 119 is configured for releaseablycoupling to an external pressure transducer 121 or to a standardsyringe. For example, adapter 119 comprises a female Luer lockconnection. Adapter 119 is coupled to main lumen 200 via tubing 117 toprovide a pathway from main lumen 200 to external pressure transducer121 so that blood pressure can be measured. In embodiments that don'tcomprise a lumen, apparatus 102 may or may not comprise openings 109.

In the illustrated embodiment, insulated conducting wire 202 exitselongate member 104 through an exit point 210. Exit point 210 may besealed with an adhesive or a polymeric material. Conducting wire 202extends along elongate member 104 from distal region 106 to proximalregion 108 and is electrically coupled to catheter connector cable 116within hub 114 by an electrical joint 206. Soldering or another wirejoining method can be used to make joint 206. Catheter connector cable116 terminates with a connector 118 that can mate with either the ECGinterface unit 120, or a separate extension connector cable (not shown).Catheter connector cable 116 and connector 118 may be made of materialssuitable for sterilization, and may insulate the user from energytraveling through the conductor.

In the illustrated embodiment, elongate member 104 is coupled to tubing117 at proximal end 212 of elongate member 104. Tubing 117 may be madeof a polymeric material that is more flexible than elongate member 104.A suitable material for tubing 117 is polyvinylchloride (PVC), oranother flexible polymer. Tubing 117 is coupled to adapter 119. Thisconfiguration provides a flexible region for the user to handle whenreleaseably coupling external pressure transducer 121, or other devicesto adapter 119. Couplings between elongate member 104 and tubing 117,and between tubing 117 and adapter 119 may be made with an adhesive suchas a UV curable adhesive, an epoxy, or another type of bonding agent.

A hub 114 surrounds electrical joint 206 and proximal end 212 ofelongate member 104 in order to conceal the aforementioned connections.The hub 114 may be made of a polymeric material, and may be filled witha filling agent 208 such as an epoxy, or another polymeric material, inorder to hold catheter connector cable 116 and tubing 117 in place.

Referring now to FIG. 4, there is illustrated a side cross-sectionalview of an embodiment of functional tip region 110. In one embodiment,functional tip region 110 comprises one energy delivery device 112configured as an active electrode in a bullet shape. Energy deliverydevice 112 may be about 0.10 cm to about 0.20 cm in length and may havean outer diameter of about 0.02 cm to about 0.06 cm. For example, energydelivery device 112 may have a length of about 0.15 cm (about 0.059″)and may have an outer diameter of about 0.04 cm (about 0.016″). Energydelivery device 112 is coupled to an end of conducting wire 202, whichmay also be made out of a conductive and radiopaque material. Energy maybe delivered through energy delivery device 112 to tissue, and maytravel through the patient to grounding pad 130, which is connected togenerator 128. Additionally, action potentials or voltage measured fromtissue through energy delivery device 112 travel through conducting wire202 to ECG recorder 126. Alternate embodiments of energy delivery device112 may be configured in shapes other than a bullet. These shapesinclude a spherical shape, a rounded shape, a ring shape, a semi-annularshape, an ellipsoid shape, an arrowhead shape, a spring shape and acylindrical shape, among others.

Referring now to FIG. 5, there is illustrated an alternate embodiment ofa functional tip region 500. Functional tip region 500 comprises oneenergy delivery device 502 in a ring configuration. Conducting wire 504covered with electrical insulation 506 is coupled to the energy deliverydevice 502, and energy delivery device 502 is positioned around theperimeter of a single opening 508 that provides a pathway between mainlumen 510 and a patient's body. Another similar embodiment to functionaltip region 500 comprises an active electrode in a partially annularshape (not shown).

In further embodiments, a functional tip may comprise multipleelectrodes. Such electrodes may operate in a monopolar mode as with theembodiments detailed in FIGS. 2 and 5.

In order to measure pressure at the distal region 106 of the apparatus102, an external pressure transducer 121 may be coupled to apparatus102. For example, adapter 119 may be releaseably coupled to externaltubing 123 that is coupled to external pressure transducer 121. In use,external tubing 123 may be flushed with saline to remove air bubbles.When apparatus 102 is positioned in a blood vessel in a body, pressureof fluid at distal region 106 exerts pressure through openings 109 onfluid within main lumen 200, which exerts pressure on saline in externaltubing 123, which exerts pressure on external pressure transducer 121.The at least one opening 109 and lumen 200 provide a pressure sensingmechanism in the form of a pressure transmitting lumen for coupling topressure transducer 121. External pressure transducer 121 produces asignal that varies as a function of the pressure it senses. Externalpressure transducer 121 may also be releaseably electrically coupled toa pressure monitoring system 125 that converts the transducer's signaland displays a pressure contour as a function of time. Thus, pressuremay be optionally measured and/or recorded and, in accordance with oneembodiment of a method aspect as described further herein below, used todetermine a position of the distal region 106 in a patient's body. Inthose embodiments of apparatus 102 that do not comprise any lumens, apressure transducer may be mounted at or proximate to distal region 106and coupled to pressure monitoring system 125 via an electricalconnection.

Referring now to FIG. 6, there is illustrated a side cross-sectionalview of an alternate embodiment of apparatus 600 which operates in abipolar mode. Apparatus 600 comprises an elongate member 602 having adistal region 604, and a proximal region 606. Elongate member 602 has atleast one lumen 608 extending from proximal region 606 to distal region604. In some embodiments, the outer diameter of elongate member 602tapers down to distal region 604. In alternate embodiments the outerdiameter of elongate member 602 remains substantially constant along itslength.

Distal region 604 terminates at functional tip region 610. Functionaltip region 610 comprises one energy delivery device 612 and onereference electrode 614. In an alternate embodiment comprising a kitincluding apparatus 600 and at least one of a sheath, such as sheath800, and a dilator, such as dilator 910, a reference electrode may belocated at the distal tip 912 of dilator 910 or at the distal tip 802 ofsheath 800. Both the energy delivery device 612 and reference electrode614 can be configured in various shapes. These shapes include aspherical shape, a rounded shape, a ring shape, a semi-annular shape, anellipsoid shape, an arrowhead shape, a spring shape and a cylindricalshape, among others. One or more radiopaque markings may be affixed toelongate member 602 to highlight the location of the transition fromdistal region 604 to the remainder of elongate member 602, or otherimportant landmarks on apparatus 600. Alternately, the entire distalregion 604 of apparatus 600 may be radiopaque. Distal region 604 maydefine at least one opening 613 in fluid communication with lumen 608.

In an alternate embodiment, the distal region 604 comprises a curveportion. Curve length may be about 4 cm (about 1.57″) to about 6 cm(about 2.36″) and the curve may traverse about 225 to about 315 degreesof the circumference of a circle. For example, the curve may be about 5cm in length and may traverse about 270 degrees of the circumference ofa circle. Such an embodiment may be useful to avoid unwanted damage tocardiac structures.

In some embodiments, the curve portion begins about 0.5 cm to about 1.5cm proximal to energy delivery device 612, leaving an approximately 1 cm(about 0.39″) straight portion in the distal region 604 of apparatus600. This ensures that this initial portion of apparatus 600 will exitdilator 910 (see FIG. 9 below) without curving, enabling the operator toeasily position the apparatus 600, for example, against a septum asdescribed further below. This feature further ensures that the distalregion 604 of apparatus 600 will not begin curving within the atrialseptum.

Lumen 608 extends from proximal region 606 along elongate member 602 andthrough distal region 604 of apparatus 600. At least one opening 613 atthe distal region 604 provides a pathway between lumen 608 and theenvironment surrounding distal region 604, such as a desired locationwithin a patient's body. Openings 613 may be sufficiently dimensioned toeasily aspirate blood to and through lumen 608 and to inject radiopaquecontrast; however, openings 613 may be limited in number and dimensionso that they do not compromise the structural integrity of distal region604. In order to facilitate even distribution of contrast agent and toprevent pooling in lumen 608 at distal region 604, openings 613 may bedimensioned such that distally located openings are larger thanproximally located openings. The location of openings 613 is as close toenergy delivery device 612 as possible so that only a small portion ofapparatus 600 is required to extend from dilator 910 and sheath 800 inorder to measure pressure.

Proximal region 606 comprises a hub 616, an active connector cable 618,a reference connector cable 620, tubing 626 and an adapter 628. Hub 616may comprise a curve direction or orientation indicator that is locatedon the same side of apparatus 600 as the curve in order to indicate thedirection of the curve. Proximal region 606 may also have one or moredepth markings 630 to indicate distances from energy delivery device612, or other important landmarks on apparatus 600. Adapter 628 isconfigured to releaseably couple apparatus 600 to an external pressuretransducer. Both active connector cable 618 and reference connectorcable 620 may connect to an ECG interface unit.

Energy delivery device 612 may be coupled to an insulated conductingwire 622. Conducting wire 622 carries electrical energy from a generatorto the energy delivery device 612. Conducting wire 622 also carriesaction potentials or voltage measured by energy delivery device 612 toan ECG recorder. Conducting wire 622 extends through main lumen 608 ofapparatus 600. Conducting wire 622 extends along elongate member 602from distal region 604 to proximal region 606 and is electricallycoupled to active connector cable 618 within hub 616.

Reference electrode 614 may be coupled to an insulated conducting wire624. Conducting wire 624 carries electrical energy from a patient to agenerator. Conducting wire 624 also carries action potentials or voltagemeasured by reference electrode 614 to an ECG recorder. Conducting wire624 extends through main lumen 608 of apparatus 600. Conducting wire 624extends along elongate member 602 from distal region 604 to proximalregion 606 and is electrically coupled to reference connector cable 620within hub 616.

In the bipolar mode, RF energy is delivered through energy deliverydevice 612 (i.e. active electrode 612), and returns to the generatorthrough reference electrode 614. The use of an active and a referenceelectrode attached to apparatus 600 eliminates the need for a groundingpad to be attached to the patient. With an active-return electrodearrangement at functional tip region 610, action potentials or voltagemeasured by the energy delivery device 612 are with reference to theground or reference electrode 614 located at the function tip region610. The ECG recorder assigns a zero potential value to the referenceelectrode 614. A zero potential or ground electrode within the ECGrecorder or placement of a ground electrode on the patient is notrequired and a higher fidelity recording may be facilitated.

Referring now to FIG. 7, there is illustrated a side cross-sectionalview of proximal 706 and distal 704 regions of an alternate embodimentof an apparatus 700 that does not require an external pressuretransducer. In this embodiment the pressure sensing mechanism comprisesan on-board pressure transducer 708 coupled by an adhesive to elongatemember 702 at distal region 704. The pressure transducer 708 isconfigured at distal region 704 such that pressure close to energydelivery device 710 can be transduced. The on-board pressure transducer708 is electrically coupled to a pressure communicating cable 712 toprovide power to transducer 708 and to carry a pressure signal toproximal region 706 of the apparatus 700. Pressure communicating cable712 terminates in a monitoring system connector 714 that is configuredto be releaseably coupled to a pressure monitoring system. The pressuremonitoring system converts the pressure signal and displays pressure asa function of time. In the embodiment of FIG. 7, a main lumen such asthe main lumen 200 of FIG. 2 is not required for fluid communicationwith an external pressure transducer 121 (shown in FIG. 1). In addition,this embodiment does not require openings, such as openings 109 shown inFIG. 1, at distal region 704 for fluid communication with a main lumen.However, a lumen with openings may be provided for injecting oraspirating fluids, if desired.

Optionally, to measure and record ECG at the distal region of theapparatus 102, ECG recorder 126 is connected to apparatus 102 throughthe ECG interface unit 120. Hub 114 is coupled to catheter connectorcable 116 that is coupled to connector 118 as shown in FIG. 1. Connector118 is attached to ECG Interface unit 120. When apparatus 102 ismaneuvered in a patient's body, particularly in a heart, electricalaction potentials or voltage detected by energy delivery device 112 aretransmitted along conducting wire 202 and catheter connector cable 116,through ECG interface unit 120 and are captured and displayed on ECGrecorder 126. Different locations in a heart are at different electricpotentials and thus the voltage measured varies as the position ofenergy delivery device 112 is varied. A conversion circuit within ECGrecorder 126 may be used to convert the measured voltage or potentialinto a picture or waveform recording that varies as a function of time.

Sheaths and Dilators

In order to create a perforation in the heart, apparatus 102 isdelivered to the heart using a guiding sheath and dilator known to thoseof ordinary skill in the art. FIGS. 8A and 8B show alternate embodiments800 and 810 of a guiding sheath. Guiding sheaths 800 and 810 bothcomprise distal tips (802 and 812, respectively) and proximal hubs 804.Distal tip 802 is configured and shaped for approaching the heart viathe inferior vena cava (IVC) while distal tip 812 is configured andshaped for approaching the heart via the superior vena cava (SVC).Distal tip 812 may comprise a curve of between about 45 degrees to about90 degrees with a relatively short radius such that, when sheath 810 isadvanced into the left atrium, the entire curve may sit within the leftatrium. Then, through rotating the sheath shaft, the orientation ofdistal tip 812 may be rotated about its lateral axis. One purpose of thesheath is to provide a conduit for any catheters or other devices thatmay be introduced therethrough into a patient's heart and to orient thedevices such that it facilitates their use. Thus, various curves wouldbe useful depending on the final desired position of the sheath withinthe patient's heart. The curve of distal tip 812 shown in FIG. 8B may beparticularly useful for mitral valve access for balloon valvuloplastyand/or RF ablation of the left side of the heart. Sheaths 800 and 810may both define a lumen through which a dilator or other device may bedelivered. In addition, sheaths 800 and 810 may comprise one or moreradiopaque markers or reference electrodes.

FIG. 9 illustrates a dilator 910 comprising a tip 912 at the distal endthereof and a proximal hub 914. Dilator 910 may be useful whenapproaching the heart via the IVC due to the shape thereof. Dilator 910may have one or more radiopaque markers or reference electrodes. Inaddition, dilator 910 may define a lumen sized to allow for passage ofsaid dilator over a guidewire or for delivery of Apparatus 102 throughsaid dilator.

FIGS. 10A, 10B and 10C show alternate embodiments of dilator shapes thatmay be useful when approaching the heart via the SVC. As illustrated inFIGS. 13A, 13B, 14A and 14B below, and as will be discussed in greaterdetail, performing a trans-septal perforation utilizing a sheath anddilator typically involves several steps, including positioning theenergy delivery device against the septum and advancing the dilatorand/or sheath across the septum. Each of these steps may require thedilator to be configured in a specific manner in order to perform thedesired function. For example, in order to position the energy deliverydevice against the septum for perforation, it may be desirable toposition the energy delivery device at an angle of about 80 to about 100degrees relative to the surface of the septum. In some embodiments, theenergy delivery device should be positioned substantiallyperpendicularly to the septum prior to perforation. In order to achievethis results, a dilator as shown in FIG. 10A (1010) or 10B (1020) may beemployed. Both of these dilators comprise distal tips (1012 and 1022,respectively) that are shaped so as to position the energy deliverydevice appropriately against the septum when the heart is approached viathe SVC.

Once the perforation is created, the dilator and/or sheath may beadvanced across the perforation into the left atrium. In order toachieve this most efficiently, it may be advantageous to employ adilator that can transmit a longitudinal force applied at a proximal endthereof into a force directed at the perforation in order to dilate theperforation sufficiently. In some embodiments, a dilator 1030, asillustrated in FIG. 10C, may be used. Dilator 1030 comprises a distaltip 1032 with a relatively gentle curve (less than 90 degrees) thatlends itself to transmitting mechanical force applied at a proximal endof the dilator to advance the dilator through the perforation. In thisconfiguration, the apparatus comprising the energy delivery device mayserve to act as a rail to prevent dilator 1030 from slipping down theseptum. Alternatively, dilator 1010 may be used to advance the dilatorand/or sheath through the perforation. In such an embodiment, as alongitudinal force is applied at a proximal end of the dilator, thedilator and/or sheath may flex and push against the free wall of theright atrium, thereby providing back support and directing force towardsthe septum. The specific curve used in this embodiment may depend on thespecific geometry of the right atrium of the patient. Any of dilators1010, 1020 and 1030 may comprise hubs 914 as well as radiopaque markersand/or reference electrodes. In alternate embodiments, one or more ofthe sheath and dilator may be steerable and/or articulating, whereby ashape of the sheath or dilator may be adjusted during the course of theprocedure. This may allow for a user to define the precise curverequired for each step of the trans-septal perforation.

Referring now to FIGS. 11 and 12 there is illustrated Apparatus 102inserted through dilator 910 and sheath 800 within a heart 1600 of apatient. In these figures, the heart has been approached via theinferior vena cava. FIGS. 13 and 14 provide illustrations of apparatus102 inserted into the heart via the superior vena cava. FIGS. 13A and14A show apparatus 102 inserted through dilator 1010 while FIGS. 13B and14B show apparatus 102 inserted through dilators 1020 and 1030,respectively. In all of FIGS. 13 and 14 the dilators are inserted withinsheath 810.

Method

Broadly speaking, embodiments of the present invention provide a methodof surgical perforation via the delivery of electrical, radiant orthermal energy. The method may typically involve at least the followingsteps: introducing an apparatus comprising an energy delivery deviceinto a patient's heart via the patient's superior vena cava; positioningthe energy delivery device at a first location adjacent the material tobe perforated; and perforating the material by delivering energy via theenergy delivery device; wherein the energy is selected from the groupconsisting of electrical energy, radiant energy and thermal energy.

As one specific example of this method, operational steps 1600 for amethod of creating a trans-septal perforation in accordance with anembodiment of the invention are outlined in flowchart form in FIGS. 16Aand 16B. In accordance with a method aspect of the invention forcreating a trans-septal perforation, the apparatus, dilator and sheathmay be introduced into the heart via the SVC (step 1601). Alternatively,the heart may be accessed via the IVC, as shown in FIGS. 11 and 12. Inorder to deliver the tip of the dilator against the upper region of theatrial septum 1102 (step 1602) a guiding sheath and dilator with a lumensufficient to accommodate the outer diameter of the Apparatus 102 may beintroduced into a patient's vasculature. In alternate embodiments of thepresent invention, the procedure may be performed without a sheathand/or dilator. In either case, the method comprises steps ofintroducing one or more devices and/or apparatuses into the patient'svasculature and advancing the devices/apparatuses through thevasculature into the patient's heart. Access to the vasculature may beachieved through a variety of veins large enough to accommodate theguiding sheath and dilator and the present invention is not limited inthis regard. The guiding sheath and dilator may be advanced togetherthrough the vasculature. In one embodiment, illustrated in FIGS. 11 and12, they approach the heart from the Inferior Vena Cava (IVC) 1106 andproceed into the Superior Vena Cava (SVC) 1108 of the heart 1100. Inaccordance with this embodiment, access to the vasculature may be gainedvia the femoral vein. The sheath and dilator may then be withdrawn fromthe SVC 1108, into the right atrium 1110. In another embodiment,illustrated in FIGS. 13-14, the guiding sheath and dilator approach theheart via the SVC and proceed directly into the right atrium. Inaccordance with this alternate embodiment, access to the vasculature maybe gained via one or more of the subclavian vein, the brachial vein, theaxillary vein and the jugular vein. As noted above, methods that includeintroducing the apparatus, sheath and/or dilator via the Superior VenaCava, as illustrated in FIGS. 13-14, should not be confused withIVC-approach methods where the distal parts of the guiding sheath anddilator temporarily entering the SVC from an inferior approach.

Contrast agent may be delivered through the dilator while positioningthe dilator and sheath along the atrial septum 1102. The sheath anddilator are now positioned within the right atrium 1110 of heart 1100 sothat the tip of the dilator is located against the upper region of theatrial septum 1102 (step 1603).

Once the tip of the dilator is in position against the upper region ofthe atrial septum 1102, apparatus 102 can be advanced through thedilator until functional tip region 110 is located distally to the tipof the dilator (step 1604). Distal region 106 of apparatus 102 ispliable so that the curve 115 straightens out within the dilator andtakes on the shape of the dilator as it is advanced to the atrial septum1102. Apparatus 102 is coupled to the ECG recorder 126 and an ECGtracing monitored through energy delivery device 112, known to those ofordinary skill in the art, may be shown on ECG recorder 126. Thetechnique for obtaining an ECG tracing was previously described. In someembodiments, apparatus 102, the dilator and the sheath are now draggedalong the atrial septum 1102 while monitoring the ECG tracing on the ECGrecorder 126 (step 1606). Confirmation of the position of energydelivery device 112 of apparatus 102 against the fossa ovalis 1104 ismade once a distinctive change in the ECG tracing on ECG recorder 126 isobserved. This is due to energy delivery device 112 advancing over theregion of the fossa ovalis 1104 which is membranous in comparison withthe muscular atrial septum 1102.

H. Bidoggia et. al. (1991) who performed experiments on the usefulnessof the intracavitary ECG (recorded using a trans-septal needle) in thelocalization of the fossa ovalis states that when the tip of the needlewas laid against the fossa ovalis floor, the endoatrialelectrocardiogram registered a slight or no injury curve, even when thepressure was sufficient to perforate the septum. On the contrary,pressure on any other areas of the muscular septum or atrial wallselicited a bizarre monophasic injury curve. This shows that the ECGsignal recorded by a surgical device while on the membranous fossaovalis will be damped in comparison with the ECG signal recorded on themuscular areas of the atrial septum or atrial walls. This difference inECG signal may be useful in locating the region of the fossa ovalis as asurgical device is positioned within a heart. ECG may be displayed on ascreen and/or printed on a chart, for example. The distinctive changemay be signaled for observation as well using an alarm such as anaudible or visual signal.

In some embodiments, radiopaque contrast agent or dye delivered throughapparatus 102 will be directed through the openings 109 in functionaltip region 110 into the tissue of the fossa ovalis 1104 in order tostain the tissue and make it more visible under radiographic imaging(step 1608). Using fluoroscopy, the stained region of the fossa ovalis1104 can be seen as a dark patch in contrast to the atrial septum 1102,which appears as a lighter color. Functional tip region 110 may now beeasily directed towards the fossa ovalis 1104.

In embodiments whereby the heart is approached via the SVC (for example,FIGS. 13A and 13B), one or more of the dilator, sheath and apparatus maybe shaped and or configured such that, upon positioning the apparatuswithin the right atrium 1110, functional tip region 110 may bepositioned at an angle of about 80 degrees to about 100 degrees relativeto the fossa ovalis 1104. In further embodiments, functional tip region110 may be positioned substantially perpendicularly relative to thefossa ovalis 1104. Such a position may be achieved, for example, byusing dilators 1010 or 1020, as shown in FIGS. 13A and 13B.

The position of apparatus 102 may also be confirmed by monitoringpressure at the functional tip region 110 (step 1610). Apparatus 102 iscoupled to external pressure transducer 121 and a right atrial pressurecontour, known to those of ordinary skill in the art, may be displayedon monitoring system 125. The technique for obtaining a pressure contourwas previously described.

The position of functional tip region 110 and energy delivery device 112may be additionally confirmed using an imaging modality such asfluoroscopy. Under fluoroscopy, radiopaque markings associated withdistal region 106 of apparatus 102 may be aligned with a radiopaquemarker located distally on the dilator such that functional tip region110 of apparatus 102 is located at the fossa ovalis 1104. Alternately,radiopaque markings associated with distal region 106 of apparatus 102may be aligned with a radiopaque marker located distally on the sheathsuch that functional tip region 110 of apparatus 102 is located at thefossa ovalis 1104 (step 1612).

The position of functional tip region 110 of apparatus 102 is evaluatedand if the desired position is not confirmed (step 1614, No branch),step 1606 may be repeated. If confirmed (step 1614, Yes branch), energymay be delivered to create the perforation. For example, generator 128may be activated and RF energy may be delivered through apparatus 102 tomake a perforation (step 1616). As mentioned above, the perforation mayalternatively be created using radiant (e.g. laser) or thermal energy.

Referring to FIGS. 12 and 14, functional tip region 110 of apparatus 102is thereafter advanced through the perforation and into a secondlocation (step 1618). Advancement may be monitored under fluoroscopyusing radiopaque markings on the distal region 106 of apparatus 102. Insome embodiments, the second location is the left atrium 1112 of theheart. The distal region 106 of apparatus 102 is advanced incrementallyinto the left atrium 1112 through the dilator, for example, in about 1cm (about 0.39″) increments. After the first 1 cm of distal region 106of apparatus 102 has been advanced out of the dilator across the atrialseptum 1102, into left atrium 1112, the curve portion 115 of distalregion 106 of apparatus 102 establishes its curved shape within the leftatrium 1112. In other words, the distal tip of apparatus 102 may bedirecting in a desired direction, for example away from cardiacstructures, following perforation of the septum. An orientationindicator located on apparatus 102 may be monitored in order todetermine the direction of the distal tip of apparatus 102. The positionof depth markings 113 of apparatus 102 relative to the proximal hub ofthe dilator can be used as a guide. Additionally, advancement ofperforating apparatus 102 can be controlled by monitoring radiopaquemarkings on the distal region 106 of apparatus 102 under fluoroscopy.When the openings 109 on distal region 106 of apparatus 102 are locatedin the left atrium 1112, the evaluation of pressure contours from theleft atrium via pressure transducer 121 (step 1620) can be performed.Apparatus 102 may remain coupled to external pressure transducer 121 sothat a pressure contour at the second location can be measured and/ormonitored confirming the desired location of the distal region followingthe perforation.

Additionally, when the distal region 106 of apparatus 102 is located inthe left atrium 1112, the evaluation of the ECG tracing (step 1622) canbe performed. Apparatus 102 remains coupled to ECG recorder 126 so thatan ECG tracing at the second location can be monitored. After successfulperforation, a left atrial pressure contour known to those of ordinaryskill in the art, will be shown on monitoring system 125. In addition, aleft atrial ECG tracing, known to those of ordinary skill in the art,will be shown on the ECG recorder 126. In the event that at least one ofthe imaging, pressure contours and ECG tracings show that theperforation has been made in an undesirable location (step 1624, Nobranch), apparatus 102 may be retracted into the right atrium 1110 (step1626) and may be repositioned for another perforation attempt (step1606). If the perforation is successfully made in the correct location(step 1624, Yes branch), distal region 106 of apparatus 102 may befurther advanced through the perforation. In some embodiments, whenapparatus 102 is fully inserted into the dilator, hub 114 of theapparatus 102 will be flush against the proximal hub of the dilator, andno depth markings 113 of apparatus 102 will be visible (step 1628, FIG.16B). When fully inserted, apparatus 102 provides sufficient support topermit the dilator to be advanced over it through the perforation.

The dilator may be advanced through the perforation by applying alongitudinal force to the proximal end of the dilator. If the heart hasbeen approached via the IVC, this longitudinal force may directlyadvance the dilator through the perforation. However, in someembodiments whereby the heart has been approached via the SVC, applyinga longitudinal force may push the dilator down along the septum ratherthan through the perforation. In such embodiments, the dilator may bedesigned in such a way so that application of a longitudinal force ontoa proximal end of the dilator may advance the distal end of the dilatorthrough the perforation. For example, in FIG. 14A, dilator 1010 isshaped such that application of a longitudinal, downward force onto aproximal end of the dilator will cause a portion (1016 in FIG. 10A) ofdilator 1010 to push against the free atrial wall. This in turn willtransmit the longitudinal force in a lateral direction, thus forcing thedistal end of dilator 1010 through the perforation. Alternatively, asshown in FIG. 14B, dilator 1030 may comprise a gentle curve which lendsitself to transmitting mechanical force, such that the longitudinalforce applied at a proximal end of the dilator will advance the distalend through the perforation. In such an embodiment, apparatus 102 mayserve as a rail to support dilator 1030 and to ensure that dilator 1030does not slip down the septal wall.

In order to advance the sheath and dilator, hub 114 of apparatus 102 maybe fixed in place spatially, and both the proximal hub 914 of thedilator and proximal hub 804 of the sheath may be incrementally advancedforward, together, thus sliding the dilator and sheath over apparatus102 (step 1630). The distal tip of the dilator and the distal tip of thesheath may be monitored under fluoroscopy as they are advanced overapparatus 102 and, once the tip of the dilator has traversed theperforation and has advanced into the left atrium 1112, the tip of thesheath may then be advanced over the dilator, across the perforation andinto the left atrium 1112 as well (step 1632). In an alternate method ofadvancing the sheath and dilator into the left atrium, once distalregion 106 is fully advanced through the perforation and into the leftatrium 1112, and hub 114 of apparatus 102 is flush against proximal hub914 of the dilator, hub 114 of apparatus 102, proximal hub 914 of thedilator and proximal hub 804 of the sheath may all be advanced forwardtogether, for example under fluoroscopy. Forward momentum will cause thedistal tip of the dilator to traverse the perforation, advancing intothe left atrium 1112. The distal tip of the sheath will follow over thedilator, across the perforation and into the left atrium 1112.Alternatively, apparatus 102, the dilator and the sheath may each beadvanced independently through the perforation. For example, the sheathmay be advanced prior to the dilator.

At step 1634, the positions of distal region 106 of apparatus 102, thedistal tip of the dilator and the distal tip of the sheath may beconfirmed, for example, under fluoroscopy, to be in the left atrium1112. If not in the desired location (step 1636), step 1630 may berepeated. If the positions are confirmed (step 1636), apparatus 102 andthe dilator may now be respectively withdrawn outside the body, forexample under fluoroscopic guidance (step 1638). While maintaining theposition of the distal tip of the dilator and the distal tip of thesheath in the left atrium 1112, apparatus 102 may be withdrawn. Thedilator may then be withdrawn outside the body under fluoroscopicguidance, while maintaining the position of the distal tip of the sheathin the left atrium 1112. In some embodiments (see, for example, FIG.15), the sheath may assume its original shape once the dilator iswithdrawn. In other words, while the dilator is located within thesheath lumen, the sheath may conform to the shape of the dilator.However, once the dilator is removed, the sheath may revert to itsoriginal shape, i.e. the shape it had prior to receiving the dilatorwithin the sheath. Optionally, a contrast agent may now be injectedthrough the sheath into the left atrium 1112, blood may be aspiratedthrough the sheath from the left atrium 1112, or other devices (forexample treatment devices or diagnostic devices) or treatmentcompositions may be introduced into the left atrium 1112 through theperforation (for example, through the sheath).

As has been mentioned above, it may be advantageous, particularly inembodiments wherein the heart is approached via the SVC, to employ oneor more dilators of various configurations throughout the procedure. Forexample, a dilator having a first shape may be used to facilitatepositioning of apparatus 102 adjacent the fossa ovalis or other materialto be perforated. Subsequently, a dilator having a second shape may beused to facilitate advancement of the dilator across the perforation.These two dilator shapes may be achieved in a number of ways. Forexample, two separate dilators may be used. One embodiment may comprisetwo dilators which may be exchanged during the course of the procedure.In other words, one dilator may be used to position the apparatus forperforation and, after perforation has been completed, the dilator maybe exchanged for a second dilator configured to facilitate advancementof the dilator across the perforation.

Alternatively, another embodiment may comprise a first, more flexibledilator configured to facilitate advancement of the dilator through theperforation. A second, stiffer dilator may be located within a lumendefined by the more flexible dilator. The stiffer dilator may beconfigured to facilitate positioning of the apparatus for perforation.Thus, in use, the stiffer dilator may be inserted within the moreflexible dilator in order to position the apparatus for perforation.Once perforation has been completed, the stiffer dilator may beretracted, thus allowing the more flexible dilator to assume its naturalshape, configured to allow for advancement of the dilator through theperforation. Alternatively, another elongated support member, such as astylet, may be used instead of the second, stiffer dilator. Theelongated support may be inserted into a lumen and retracted aftertissue penetration is completed. In a further embodiment, the dilatormay be configured such that a user can modify the shape of the dilatorduring the course of the procedure. In other embodiments, the dilatormay have a single configuration throughout the procedure, asillustrated, for example, in FIGS. 13A and 14A.

The present invention in various embodiments thus provides a device andmethod that is capable of creating a perforation while determining aposition of the device in response to action potentials or measuredvoltage at a location in the heart as well as determining a position ofthe device in response to pressure at a location in the body. In someembodiments, the present invention decreases the risk of inadvertent andunwanted cardiac injury associated with creating the perforation. Onemeans for decreasing the risk of unwanted injury comprises a curve atthe distal end of the device. In further embodiments, the presentinvention also provides a method for staining the area to be perforatedin order to make it easier to locate during the perforation. Inaddition, embodiments of the present invention provide a method fordelivering a dilator and sheath over the device after the perforation.Various embodiments of dilators and sheaths are described in thespecification. The perforation may be created by the application ofenergy produced by a generator and delivered to an active tip on thedevice. The energy may be selected from the group consisting ofelectrical energy (various frequencies), radiant energy (e.g. laser) andthermal energy, amongst others. A means for determining the position ofthe device may comprise an ECG measuring device for monitoring actionpotentials or measured voltage through an active electrode in a unipolaror bipolar manner and displaying the ECG tracings on an ECG recorder. Inthis embodiment there is at least one active electrode at the functionaltip region for monitoring action potentials which are captured anddisplayed as ECG tracings on an ECG recorder. A means for determiningthe position of the device may also comprise a pressure transmittinglumen that may be releaseably coupled to an external pressuretransducer. In this embodiment, there is at least one opening near thedistal region of the device for blood or other fluid to enter and fillthe lumen and exert a measurable pressure on a coupled externaltransducer. The lumen and opening may also be useful for injectingradiopaque contrast or other agents through the device. In an alternateembodiment, the means for determining the position of the device inresponse to pressure comprises a transducer located on the deviceproximal to the functional tip.

The device of the invention may be useful as a substitute for atraditional trans-septal needle to create a trans-septal perforation.Some embodiments of the device of the present invention may have a softand curved distal region with a functional tip that uses RF energy tocreate a perforation across a septum, making the procedure more easilycontrolled and less operator dependent than a trans-septal needleprocedure. The soft distal region of the device may reduce incidents ofvascular trauma as the device is advanced through the vasculature. Theapplication of RF energy may be controlled via an electric generator,eliminating the need for the operator to subjectively manage the amountof force necessary to cross the septum with a traditional needle. Thus,the present invention may reduce the danger of applying too muchmechanical force and injuring the posterior wall of the heart.

The present invention also provides a method for the creation of aperforation in, for example, an atrial septum. ECG as well as pressuremonitoring may be advantageous in this procedure, as there is thepossibility of inadvertently perforating the aorta due to its proximityto the atrial septum. Electrical action potential or voltagemeasurements displayed as ECG tracings allow the operator to positionthe device accurately at the fossa ovalis on the septum as well asconfirm that the distal end of the device has entered the left atrium,and not the aorta or another undesirable location in the heart. As well,pressure measurements allow the operator to confirm that the distal endof the device has entered the left atrium, and not the aorta, or anotherundesirable location in the heart.

Staining the atrial septum may also be advantageous in this procedure,as it easily identifies the region of the atrial septum (fossa ovalis)to be perforated. The device may also be visible using standard imagingtechniques; however the ability to monitor both ECG and pressureprovides the operator with a level of safety and confidence that wouldnot exist using only these techniques. It should be noted, however, thata method of the present invention may be practiced without any or all ofpressure monitoring, ECG monitoring and staining and is thus intended tocomprise, in a basic form, a method of creating a perforation in atissue utilizing any intravascular approach.

In some embodiments of the present invention, the heart is approachedvia the inferior vena cava (IVC) (an ‘inferior’ approach). In suchembodiments, the device may be introduced into the patient's vasculaturevia the femoral vein and via the inferior vena cava.

In alternate embodiments, the heart may be approached via the superiorvena cava (SVC) (a ‘superior’ approach). Such embodiments may be usefulin instances where introduction via the IVC is contra-indicated. Forexample, occasionally, due to abnormalities of the venous system such asazygous continuation of the inferior vena cava or thrombosis orobliteration of the iliofemoral veins it may not be possible to gainaccess to the right atrium using a femoral approach. In addition, thestandard femoral transvenous approach to the atrial septum fortrans-septal access may be difficult in situation where the cardiacanatomy is grossly distorted such as in patients with longstanding andmarked elevation of left atrial and pulmonary artery pressures, orpatients who have previously undergone cardiac surgery. Gainingtrans-septal access from the femoral approach may also be difficult inpatients with dextrocardia, a condition in which the heart is located onthe right side of the chest rather than the left and in whom there issignificant variation in the orientation of the atrial septum.

Thus, patients requiring trans-septal punctures would benefit from adevice that utilizes a non-femoral, i.e. superior, approach and which ismore reliable and user-friendly than the trans-septal needle. Inparticular, the patient population discussed above would benefit from adevice and technique for trans-septal perforation that allows for amultiplicity of uncomplicated intravascular approaches as well asproviding a more controlled method of perforation. In such embodiments,access to the patient's vasculature may be achieved through one or moreof a brachial vein, an axillary vein, a subclavian vein and a jugularvein.

In order to create the perforation, it may be desirable to position thedevice at a specific orientation relative to the material to beperforated. For example, the device may be oriented at an angle ofbetween about 80 to about 100 degrees relative to the fossa ovalis.Achieving such an orientation using a superior approach may require theuse of dilators and/or sheaths having appropriate shapes, as have beendescribed herein above.

The present invention also provides a method for delivering the dilatorand sheath over the device into the left atrium once a successfulperforation has been created. Once again, in order to successfullyadvance the dilator and/or sheath through the perforation when using asuperior approach, it may be advantageous to employ devices withappropriate shapes and configurations, as has been described.

One of the motivations for creating a trans-septal perforation is togain access to the left side of the heart for delivery of catheters ordevices to treat left-sided heart arrhythmias or defects. An applicationof a method aspect of the present invention may involve the implantationof a device, such as an implantable pressure monitor or other sensorinto the left atrium of a patient's heart. Using an embodiment of amethod aspect of the present invention, a perforation may be createdbetween the right and left atria of a patient's heart utilizing asuperior intravascular approach, for example through a subclavian vein.Following the creation of the perforation, an implantable device may beinserted through to the left atrium and implanted at a desired location.In one embodiment, the implantable device may be initially mounted onone of an electrosurgical device, a dilator, a sheath or a guidewire,thus obviating the need for an additional device to insert theimplantable device. In additional embodiments, a pressure sensor orother device may be inserted into the left atrium after the creation ofa perforation in order to monitor pressure or some other physiologicalparameter without being permanently implanted. In other words, thedevice may be used to monitor some parameter and may then be removed, inthe same procedure, without being permanently implanted into thepatient. All of these applications are intended to be exemplary only andare not intended to limit the scope of the present invention in any way.

While the surgical device thus described is capable of perforatingliving tissue, it will be understood by persons of ordinary skill in theart that an appropriate device in accordance with the invention will becapable of perforating or removing material such as plaque or thromboticocclusions from diseased vessels as well. Furthermore, any of the hubsreferred to throughout this specification (e.g. hub 114, hub 804 and hub914) may be removable in order to facilitate exchange or removal of anydevices or components during the course of a procedure.

Persons of ordinary skill in the art will appreciate that one or morefeatures of the device and method aspects of the present invention areoptional. For example, a device may be made within the scope of theinvention without a curve portion of the distal region. Further, apressure sensing mechanism for positioning the device is optional and,in other instances, the ECG monitoring feature is optional.

The embodiments of the invention described above are intended to beexemplary only. The scope of the invention is therefore intended to belimited solely by the scope of the appended claims.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims. All publications, patents and patentapplications mentioned in this specification are herein incorporated intheir entirety by reference into the specification, to the same extentas if each individual publication, patent or patent application wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis application shall not be construed as an admission that suchreference is available as prior art to the present invention.

Embodiments of the present invention are useful, for example, for theperforation of a patient's heart tissue when an inferior approach to theheart is contraindicated. As explained above, a heart tissue perforationcan be accomplished introducing an electrosurgical apparatus via asuperior approach. The apparatus may then be positioned and a controlledamount of non-mechanical energy may then be delivered to tissue at atreatment site to create the perforation or puncture.

We claim:
 1. A method of surgical perforation, the method utilizing anapparatus having an energy delivery device at a distal end thereof and adelivery system comprising a sheath and a dilator, said methodcomprising the steps of: (i) inserting the delivery system into apatient's vasculature at a location superior to a patient's heart; (ii)advancing the delivery system into the patient's heart through asuperior vena cava; (iii) adjusting a shape of a distal portion of thedelivery system to define a first configuration such that a distal endof the delivery system is oriented substantially perpendicularlyrelative to a surface of a septum of the patient's heart; (iv) insertingthe apparatus through the delivery system to position the energydelivery device about the distal end of the delivery system; (v)positioning the delivery system such that it is braced against a freewall of a right atrium of the patient's heart and positioning saidenergy delivery device at a first location against the septum; and (vi)delivering energy via said energy delivery device to create aperforation through the septum.
 2. The method as claimed in claim 1wherein step (v) comprises staining at least a portion of said firstlocation with a radiopaque dye.
 3. The method as claimed in claim 1,wherein step (iv) comprises positioning said energy delivery device atan angle of about 80 degrees to about 100 degrees relative to saidsurface of said septum to be perforated.
 4. The method as claimed inclaim 1, further comprising a step of: (vii) adjusting the shape of thedistal portion of the delivery system to define a second configurationto facilitate advancement of the delivery system through theperforation.
 5. The method as claimed in claim 1 further comprising astep of: (vii) advancing said energy delivery device to a secondlocation through the perforation.
 6. The method as claimed in claim 5wherein said second location is a left atrium of said patient's heart.7. The method as claimed in claim 5 wherein said apparatus furthercomprises at least one pressure sensor selected from the groupconsisting of a pressure-transmitting lumen and a pressure transducerand wherein said method comprises measuring pressure.
 8. The method asclaimed in claim 1 wherein the step of (iv) inserting the apparatus isperformed prior to the step of adjusting the shape of the distal portionof the delivery system.
 9. The method as claimed in claim 1, whereinsaid patient's vasculature comprises a vein and wherein step (i)comprises inserting said apparatus into said vein, wherein said vein isselected from the group consisting of a jugular vein, a subclavian vein,a brachial vein and an axillary vein.
 10. The method as claimed in claim1, wherein said dilator is articulated and wherein the step ofpositioning said energy delivery device comprises adjusting a shape ofthe dilator to position the energy delivery device at said firstlocation.
 11. The method as claimed in claim 1, wherein said sheath isarticulated and wherein the step of positioning said energy deliverydevice comprises adjusting a shape of the sheath to position the energydelivery device at said first location.
 12. The method as claimed inclaim 1, further comprising a step of applying a longitudinal force ontoa proximal end of said dilator to advance a distal end of said dilatorthrough said perforation.
 13. The method as claimed in claim 1 whereinsaid septum is an atrial septum of said patient's heart, wherein step(vi) further comprises perforating said atrial septum by delivering saidenergy via said energy delivery device.
 14. The method as claimed inclaim 13, wherein said atrial septum comprises a fossa ovalis of saidpatient's heart, wherein step (vi) further comprises perforating saidfossa ovalis by delivering said energy via said energy delivery device.15. The method as claimed in claim 1, wherein said energy comprisesradio frequency electrical energy delivered in a pulsed manner.
 16. Themethod as claimed in claim 15, wherein said radio frequency electricalenergy comprises radio frequency energy of about 60 watts or less, avoltage from about 200 Vrms to about 400 Vrms and a duty cycle of about5% to about 50% at up to about 10 Hz.
 17. The method as claimed in claim16, wherein said radio frequency electrical energy is delivered forabout 10 seconds or less.
 18. The method as claimed in claim 1, whereina length of said energy delivery device is about 0.10 cm to about 0.20cm and wherein an outer diameter of said energy delivery device is about0.02 cm to about 0.06 cm.
 19. The method as claimed in claim 18, whereinsaid energy is delivered as a continuous wave at a frequency betweenabout 400 kHz and about 550 kHz and a voltage of between about 100 toabout 200 Vrms.